Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV
type: Dataset
description: FDA recall Z-0818-2025 — GE Medical Systems, LLC is recalling Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.
license: https://creativecommons.org/publicdomain/zero/1.0/
is accessible for free: true
is part of: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
is defined by: https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native
see also: https://agenticu.ryanjhunter.workers.dev/commons/the-research-object
date modified: 2026-06-24T07:02:03.626072+00:00
is based on: openFDA drug & device enforcement (recall) reports
  type: Dataset
  creator: U.S. Food & Drug Administration
about: Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV
  type: MedicalDevice
  manufacturer: GE Medical Systems, LLC
claims: FDA recall Z-0818-2025: GE Medical Systems, LLC is recalling Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV
claims: FDA classified recall Z-0818-2025 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0818-2025
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0818-2025
      status: recorded
  item list element: ListItem
    position: 2
    item:
      field: Product type
      value: Devices
      status: recorded
  item list element: ListItem
    position: 3
    item:
      field: Classification
      value: Class II
      status: determination
  item list element: ListItem
    position: 4
    item:
      field: Status
      value: Ongoing — the recall is still being carried out.
      status: recorded
  item list element: ListItem
    position: 5
    item:
      field: Recalling firm
      value: GE Medical Systems, LLC
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2024-11-18
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: GTIN: 00840682124737; Serial Numbers: SQBC03462 SQBD02949 SQBD00338 SQBC03366 SQBC03815 SQBC05612 SQBC05620 SQBC05627 SQBC05635 SQBC05637 SQBC05641 SQBC05642 SQBC03558 SQBD03089 SQBD04439 SQBD04457 SQBD04459 SQBD04468 SQBD04702 SQBC04948 SQBC05702 SQBD02556 SQBC03896 SQBC04666 SQBC03225 SQBD02978 SQBD01384 SQBC02115 SQBC02023 SQBD04606 SQBD01484 SQBD04811 SQBC03549 SQBC03554 SQBC03559 SQBC03888 SQBC03970 SQBC04507 SQBD00211 SQBC02666 SQBC02959 SQBD00220 SQBD00402 SQBC01921 SQBC02087 SQBC02330 SQBC03003 SQBC01843 SQBC01855 SQBC04513 SQBD00326 SQBC05544 SQBC01450 SQBC02011 SQBC04529 SQBD01491 SQBD04711 SQBC01581 SQBC01747 SQBC02108 SQBC02162 SQBC02165 SQBC02183 SQBC02595 SQBC03023 SQBC05440 SQBD00444 SQBD00581 SQBC02204 SQBC02837 SQBD02999 SQBC01275 SQBC01279 SQBC01280 SQBC01283 SQBC01286 SQBC03723 SQBC02951 SQBD03058 SQBC03476 SQBD01380 SQBC03932 SQBC03969 SQBD04515 SQBD01481 SQBD01489 SQBD01315 SQBC01923 SQBD04013 SQBD04032 SQBD04034 SQBD04292 SQBD04307 SQBC02190 SQBC01912 SQBC05459 SQBD02862 SQBD02869 SQBD02886 SQBC02729 SQBC02747 SQBC01321 SQBC01322 SQBC01333 SQBD00159 SQBD02160 SQBC04115 SQBD02228 SQBD02276 SQBC02688 SQBC02753 SQBC02902 SQBD04016 SQBC01702 SQBC01811 SQBC01857 SQBC01864 SQBC01867 SQBC01869 SQBC01871 SQBC01872 SQBC01873 SQBC03257 SQBD04646 SQBD04058 SQBD04065 SQBC02014 SQBC02020 SQBD00130 SQBD04615 SQBC05293 SQBD00470 SQBD00474 SQBD00522 SQBC05037 SQBC02025 SQBD02635 SQBD02736 SQBD02738 SQBD02751 SQBD02754 SQBC04123 SQBD01505 SQBD01510 SQBD04630 SQBC05782 SQBC02814 SQBD00160 SQBD00161 SQBD00172 SQBC03066 SQBD04342 SQBD04052 SQBD04123 SQBD04242 SQBD04250 SQBD04287 SQBD04304 SQBD04325 SQBD04344 SQBD04346 SQBD04271 SQBD03156 SQBD02176 SQBC05369 SQBD03652 SQBD01267 SQBC04784 SQBC05013 SQBC05427 SQBC03055 SQBC03059 SQBC03090 SQBC03117 SQBC03119 SQBC03124 SQBC03127 SQBC03128 SQBC03129 SQBC03424 SQBC03515 SQBC03555 SQBC03560 SQBC03567 SQBC03576 SQBC05768 SQBC05773 SQBC05775 SQBC05776 SQBC05777 SQBD00239 SQBD04355 SQBD05023 SQBD04317 SQBD02837 SQBD02838 SQ…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: US Nationwide. Global Distribution.
      status: recorded

FDA recall Z-0818-2025: GE Medical Systems, LLC is recalling Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV
type: Claim
text: The FDA logged enforcement record Z-0818-2025: GE Medical Systems, LLC is voluntarily recalling Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV — reason: Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-11-18. Affected lots/codes: GTIN: 00840682124737; Serial Numbers: SQBC03462 SQBD02949 SQBD00338 SQBC03366 SQBC03815 SQBC05612 SQBC05620 SQBC05627 SQBC05635 SQBC05637 SQBC05641 SQBC05642 SQBC03558 SQBD03089 SQBD04439 SQBD04457 SQBD04459 SQBD04468 SQBD04702 SQBC04948 SQBC05702 SQBD02556 SQBC03896 SQBC04666 SQBC03225 SQBD02978 SQBD01384 SQBC02115 SQBC02023 SQBD04606 SQBD01484 SQBD04811 SQBC03549 SQBC03554 SQBC03559 SQBC03888 SQBC03970 SQBC04507 SQBD00211 SQBC02666 SQBC02959 SQBD00220 SQBD00402 SQBC01921 SQBC02087 SQBC02330 SQBC03003 SQBC01843 SQBC01855 SQBC04513 SQBD00326 SQBC05544 SQBC01450 SQBC02011 SQBC04529 SQBD01491 SQBD04711 SQBC01581 SQBC01747 SQBC02108 SQBC02162 SQBC02165 SQBC02183 SQBC02595 SQBC03023 SQBC05440 SQBD00444 SQBD00581 SQBC02204 SQBC02837 SQBD02999 SQBC01275 SQBC01279 SQBC01280 SQBC01283 SQBC01286 SQBC03723 SQBC02951 SQBD03058 SQBC03476 SQBD01380 SQBC03932 SQBC03969 SQBD04515 SQBD01481 SQBD01489 SQBD01315 SQBC01923 SQBD04013 SQBD04032 SQBD04034 SQBD04292 SQBD04307 SQBC02190 SQBC01912 SQBC05459 SQBD02862 SQBD02869 SQBD02886 SQBC02729 SQBC02747 SQBC01321 SQBC01322 SQBC01333 SQBD00159 SQBD02160 SQBC04115 SQBD02228 SQBD02276 SQBC02688 SQBC02753 SQBC02902 SQBD04016 SQBC01702 SQBC01811 SQBC01857 SQBC01864 SQBC01867 SQBC01869 SQBC01871 SQBC01872 SQBC01873 SQBC03257 SQBD04646 SQBD04058 SQBD04065 SQBC02014 SQBC02020 SQBD00130 SQBD04615 SQBC05293 SQBD00470 SQBD00474 SQBD00522 SQBC05037 SQBC02025 SQBD02635 SQBD02736 SQBD02738 SQBD02751 SQBD02754 SQBC04123 SQBD01505 SQBD01510 SQBD04630 SQBC05782 SQBC02814 SQBD00160 SQBD00161 SQBD00172 SQBC03066 SQBD04342 SQBD04052 SQBD04123 SQB…
claim type: official_fact
review status: current
commercial influence: false
epistemic status:
  occurred: true
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: SourceCitation
  source: openFDA drug & device enforcement (recall) reports — U.S. FDA
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Devices recall, status Ongoing
  adjudicator: openFDA drug & device enforcement (recall) reports — U.S. FDA
falsifier: A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release.

FDA classified recall Z-0818-2025 as Class II
type: Claim
text: The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.
claim type: regulatory_determination
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: AdjudicativeAct
  source: U.S. FDA recall classification (openFDA enforcement)
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Class II
  adjudicator: U.S. FDA recall classification (openFDA enforcement)
falsifier: occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies.

What an FDA recall is — and is NOT
type: Claim
text: A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.
claim type: interpretation
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: false
  operative: true
grounding:
  grounding type: Interpretation
  source: Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
  source url: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
  value: a recorded enforcement action, not proof of harm or causation; not medical advice
falsifier: occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not.